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FDA 510(k)

Drive Rail System

K-Number: K220809 · 2022-04-08

ApplicantOrthoPediatrics Corp.
Decision Date2022-04-08
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Drive Rail System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K220809. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Drive Rail System?

Drive Rail System is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K220809.

When did Drive Rail System receive FDA 510(k) clearance?

Drive Rail System received FDA 510(k) clearance on 2022-04-08, under 510(k) number K220809.

Who is the listed applicant for Drive Rail System?

The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Drive Rail System?

The FDA product code for Drive Rail System is KTT.

Other records listing OrthoPediatrics Corp. as applicant

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Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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